TWI579015B - Cardiac pacemaker and regulating method thereof - Google Patents

Description

Heart rhythm adjustment device and adjustment method thereof

The present disclosure relates to a heart rhythm adjusting device and a regulating method thereof, and more particularly to a heart rhythm adjusting device adjusted according to a blood pulse signal and a regulating method thereof.

The existing Pacemaker is an Open-loop system, which is a function of non-sensing and feedback control. Usually, after a period of evaluation of the patient, the heart rhythm regulator is set to the patient. The best heart rhythm is implanted in the patient. After implantation in the body, the heart rhythm regulator stimulates the myocardial rhythm with the same beat.

However, a fixed heart rhythm will extend other physiological effects. For example, if the blood pressure is too low, it cannot be recovered by the heartbeat, which leads to temporary hypoxia. For example, when exercising, it is impossible to improve the motor function through the acceleration of the heartbeat, and it is not possible to slow down the movement state by slowing the heartbeat.

Such physiological effects may further cause damage to physiological structures, such as long-term gradual hypoxia and thus affect consciousness and intelligence, and cardiovascular diseases such as blood vessel wall damage, valve damage, muscle hypoxia, Blood pressure is not balanced.

Current methods for assessing autonomic nervous activity, except directly at Outside the sensing circuit, the state of the adjustment is evaluated by the Heart Rate Variability (HRV) related parameters. However, since the beating frequency of the heart is the rhythm fixed by the heart rate regulator, there is no rhythm variability. It is not possible to assess the change in regulation from the rhythm variability, ie this method is completely unusable in patients with a rhythm regulator. The biggest difficulty of the current technology is how to obtain the adjusted parameters under fixed rhythm conditions.

One aspect of the present disclosure is to provide a heart rate adjustment device including a control unit, a sensing unit, and an analysis unit. The control unit is configured to output a heartbeat control signal corresponding to the beating frequency of the heart. The sensing unit is used to extract blood pulse signals. When the heart rate control signal has the first fixed rhythm, the analyzing unit analyzes the amplitude of the blood pulse signal and the rebound wave time of the blood pulse signal, and outputs an adjustment parameter, and the control unit uses the heart rate control signal according to the adjustment parameter. The first fixed rhythm is adjusted to a different second fixed rhythm.

A second aspect of the present disclosure is to provide a heart rhythm adjustment method comprising: outputting a beat rate of a heart rhythm control signal corresponding to a heart; extracting a blood pulse wave signal; and analyzing a blood pulse wave when the heart rate control signal has a first fixed rhythm The amplitude of the signal and the rebound time of the blood pulse signal; the adjustment parameter is output according to the amplitude of the blood pulse signal and the rebound wave time of the blood pulse signal; and the heart rhythm control signal is adjusted from the first fixed rhythm to the phase according to the adjustment parameter The second fixed rhythm of the difference.

300‧‧‧heart rate adjustment device

310‧‧‧Sensor unit

320‧‧‧Analysis unit

330‧‧‧Control unit

A1, A2, A3‧‧‧ amplitude

T1, T2, T11, T12‧‧ ‧ time

Vpul‧‧‧ blood pulse signal

Vpar‧‧‧ adjustment parameters

Vcon‧‧‧ heart rate control signal

Ft‧‧‧Preset

500‧‧‧ Heart rate adjustment method

S510~S550‧‧‧Steps

The above and other objects, features, advantages and embodiments of the present invention will become more apparent. However, it should be understood that many features are not shown to scale in order to comply with the actual use of the industry. In fact, the dimensions of many of the features may be arbitrarily increased or decreased in order to clarify the following discussion.

[Fig. 1] is a schematic diagram showing a blood pulse wave signal in a human body; [Fig. 2] is a schematic view showing an amplitude of a blood pulse wave signal and a rebound wave time thereof according to an embodiment of the present disclosure; [Fig. 3] A schematic diagram of a heart rhythm adjustment apparatus according to an embodiment of the present disclosure; [Fig. 4] is a schematic diagram showing spectral values in accordance with an embodiment of the present disclosure; and [Fig. 5] illustrates one of the present disclosures. A schematic diagram of a heart rhythm adjustment method in an embodiment.

The following disclosure provides many different embodiments or illustrations for implementing different features of the invention. The elements and configurations of the specific illustrations are used in the following discussion to simplify the disclosure. Any examples discussed are for illustrative purposes only and are not intended to limit the scope and meaning of the invention or its examples. In addition, the present disclosure may repeatedly recite numerical symbols and/or letters in different examples, and these repetitions are for simplicity and elaboration, and the following discussion is not specified by itself. Relationship between different embodiments and/or configurations.

Regarding the "coupling" or "connection" used in this article, It can be noted that two or more elements are directly in physical or electrical contact with each other, or indirectly in physical or electrical contact with each other, and "coupled" or "connected" may also mean that two or more element elements operate or act in each other. The use of the terms first, second, and third, etc., is used to describe various elements, components, regions, layers and/or blocks. However, these elements, components, regions, layers and/or blocks should not be limited by these terms. These terms are only used to identify a single element, component, region, layer, and/or block. Thus, a singular element, component, region, layer and/or block may be referred to as a second element, component, region, layer and/or block, without departing from the spirit of the invention. As used herein, the term "and/or" encompasses any combination of one or more of the listed associated items.

Please refer to Figure 1 for the blood pulse signal in the human body. schematic diagram. Generally speaking, the beating frequency of the heart in the human body is a fixed rhythm (for example, 70 to 80 times per second), and blood pulse signals can be obtained by measuring pulse diagnosis, blood pressure or blood volume. Figure 1 shows the arterial blood pressure (ABP) signal. It can be seen that as the beating frequency of the heart is a fixed rhythm, the arterial blood pressure also changes periodically, with the highest and lowest blood pressure in one cycle. The pressure difference is the amplitude A1. However, the rhythm does not change, and the heart adjusts the rhythm with physiological needs.

For example, when exercising, the body quickly consumes oxygen, On the one hand, by stimulating the autonomic nerves (that is, the sympathetic and parasympathetic nerves, here the sympathetic nerves), the bronchial muscles are relaxed, on the one hand, in order to make oxygen Rapidly transmitted to the body, the stimulation of the autonomic nerves also increases the frequency of the heart's beating. For example, when the ejection fraction is too low, that is, when the blood volume of the heart is too low, it is necessary to increase the beating frequency of the heart by stimulating the autonomic nerve (here, the sympathetic nerve) to increase the ejection volume rate. .

Therefore, if the patient is implanted with a heart rhythm regulator, The information on whether the autonomic nerve is stimulated can be further adjusted to adjust the rhythm of the heart rate control signal. For example, when the sympathetic nerve is given a stimulus, the rhythm is increased, and when the parasympathetic nerve is given a stimulus, the rhythm is lowered. However, the way to measure whether the sympathetic and parasympathetic nerves are stimulated or not can only be set directly on the autonomic nerve, and this method requires invasive (opening) diagnosis and treatment.

This disclosure proposes a non-invasive analysis of sympathetic nerves For a parasympathetic manner, please refer to FIG. 2, which is a schematic diagram showing the amplitude of a blood pulse wave signal and the time of its rebound wave according to an embodiment of the present disclosure. In this embodiment, the human body undergoes a Valsalva maneuver during the time period T1, that is, a sustained air-closing force, which is a movement that is often seen in daily life, such as coughing, vomiting, lifting heavy objects, and defecation. Wait. Here, for convenience only, the application of the embodiment is not limited to the Vaughan operation.

As shown in Figure 2, the arterial blood pressure is still within the initial T11 time. The periodic fluctuations are maintained stably, that is, the amplitude A1 is maintained. It should be noted that each pulse in the blood pulse signal can be regarded as a traveling wave from the heart end to the end of the blood vessel (such as wrist, neck, ankle, etc.) (not shown in the figure). And bounce back to the heart from the end of the blood vessels (such as wrists, neck, ankles, etc.) The dirty rebound wave (not shown in the figure) is composed, so the rebound wave time shown in Fig. 2 is the curve of the rebound wave time of the blood pulse signal.

It must be added that the amplitude of the blood pulse signal can be expressed The size of the blood volume ratio. For example, when the amplitude of the blood pulse signal becomes small, the volume ratio of the ejection blood volume becomes small, that is, the blood volume sent by the heart is too low. On the other hand, when the amplitude of the blood pulse signal becomes large, the volume ratio of the ejection blood volume becomes large, that is, the blood volume sent by the heart is too high. In addition, the amount of rebound wave time of the blood pulse signal can indicate the state of the sympathetic nerve and the parasympathetic nerve. For example, when the rebound wave time of the blood pulse signal becomes small, it means that the sympathetic nerve is stimulated. Conversely, when the rebound wave time of the blood pulse signal becomes large, it represents that the parasympathetic nerve is stimulated.

As shown in Figure 2, within the T12 time after the T11 time It can be seen that the amplitude of the blood pulse signal is reduced from the original amplitude A1 to the amplitude A2, and the rebound wave time of the blood pulse signal is gradually reduced. That is to say, the ejection volume ratio becomes small and the sympathetic nerve is stimulated during the time T12. It can be seen in the T2 time after the T12 time that the amplitude of the blood pulse signal is increased from the original amplitude A2 to the amplitude A3 due to the end of the air-tightening force, and the rebound wave time of the blood pulse signal is gradually increased. . That is, the ejection volume rate becomes large and the parasympathetic nerve is stimulated during the T2 time, so the heart rate adjusting device 300 in Fig. 3 of the present disclosure captures the amplitude of the blood pulse wave signal and the rebound wave time thereof to determine the ejection. Information on volumetric ratio, autonomic nerves (sympathetic and parasympathetic).

Please refer to FIG. 3, which illustrates an embodiment in accordance with the present disclosure. A schematic diagram of a heart rate adjustment device 300. Heart rhythm adjustment device 300 includes a sense The measuring unit 310, the analyzing unit 320 and the control unit 330. The control unit 330 is configured to output the beat frequency of the heart corresponding to the heart rate control signal Vcontrol, that is, in this embodiment, the central adjustment device 300 is disposed in the human (patient) body to assist the stable beating of the heart. The heart rate control signal Vcontrol has an initial fixed rhythm (eg, 80 times per second) that is stimulated by the first fixed rhythm when placed in the human body.

As shown in FIG. 3, the sensing unit 310 is used to capture the first image. The blood pulse signal Vpul is shown. The sensing unit 310 can be a photo-sensing device (such as a red light, an infrared light emitting receiver), a piezoelectric sensor, and any sensor that can capture the blood pulse signal Vpul. The sensing unit 310 can also be an intrusive sensor or a non-intrusive sensor, and the present invention is not limited thereto.

When the heart rate control signal Vcon has the first fixed rhythm, The analyzing unit 320 is configured to analyze the amplitude of the blood pulse wave signal Vpul and the rebound wave time of the blood pulse wave signal Vpul as shown in FIG. 2 . And according to the output adjustment parameter Vpar, the control unit 330 is configured to adjust the heart rate control signal Vcon from the first fixed rhythm to the different second fixed rhythm according to the adjustment parameter Vpar. For example, please refer to FIG. 2 together. When the analyzing unit 320 receives the amplitude of the blood pulse wave signal Vpul from the original amplitude A1 to the amplitude A2 during the time T12, that is, the analyzing unit 320 obtains the ejection. After the information of the volume ratio becomes smaller, the adjustment parameter Vpar is output, and the content of the adjustment parameter Vpar may be added 5 times per second or 10 times per second, but not limited thereto. Therefore, when the control unit 330 receives the adjustment parameter Vpar, the first fixed rhythm (80 times per second) of the original heart rate control signal Vcon is increased to a second fixed rhythm (85 times per second or 90 times per second). For another example, during the T2 time, when the analyzing unit 320 When the amplitude of the blood pulse signal Vpul is increased from the original amplitude A2 to the amplitude A3, that is, the analyzing unit 320 obtains the information that the ejection volume ratio becomes large, and outputs the adjustment parameter Vpar, wherein the content of the adjustment parameter Vpar may be 5 times per second or 10 times per second, but not limited to this. Therefore, when the control unit 330 receives the adjustment parameter Vpar, the first fixed rhythm (90 times per second) of the original heart rate control signal Vcon is reduced to a second fixed rhythm (85 times per second or 80 times per second). It should be noted that the first fixed rhythm in the T2 time is the second fixed rhythm after the previous T12 time adjustment, but the disclosure is not limited thereto, and the second fixed rhythm adjusted at each moment can be used as The first fixed rhythm of the next moment.

In addition, during the time T12, when the analysis unit 320 receives The rebound wave time of the blood pulse signal Vpul gradually becomes smaller, that is, the analysis unit 320 outputs the adjustment parameter Vpar after obtaining the information that the sympathetic nerve is stimulated, wherein the content of the adjustment parameter Vpar may be 5 times per second or 10 times per second. Times, but not limited to this. Therefore, when the control unit 330 receives the adjustment parameter Vpar, the first fixed rhythm (80 times per second) of the original heart rate control signal Vcon is increased to a second fixed rhythm (85 times per second or 90 times per second). For example, when the rebound wave time of the blood pulse signal Vpul received by the analyzing unit 320 gradually becomes larger, that is, the analyzing unit 320 obtains the information that the parasympathetic nerve is stimulated, and outputs the adjustment parameter Vpar, wherein the content of the adjustment parameter Vpar may be 5 times per second or 10 times per second, but not limited to this. Therefore, when the control unit 330 receives the adjustment parameter Vpar, the first fixed rhythm (90 times per second) of the original heart rate control signal Vcon is reduced to a second fixed rhythm (85 times per second or 80 times per second). Similarly, the first fixed section in this T2 time The law is the second fixed rhythm after the previous T12 time adjustment, but the disclosure is not limited thereto, and the second fixed rhythm adjusted at each time can be used as the first fixed rhythm of the next moment. It should be added that the amplitude of the blood pulse signal Vpul and the rebound wave time can respectively affect the adjustment parameter Vpar output by the analysis unit 320, that is, the analysis unit 320 can be based on either of the two (amplitude or rebound wave time). To output the adjustment parameter Vpar or to output the adjustment parameter Vpar according to both.

It should be added that in some embodiments, the analysis unit 320 Further, the spectrum analysis module (not shown) is used to analyze the value of the blood pulse signal Vpul in the spectrum. When the blood pulse signal Vpul changes slowly, the spectrum values fall at the low frequency position, such as In the waveform above the fourth graph, you can see that the spectrum values fall below the preset value ft. However, when the fluctuation of the blood pulse signal Vpul is fast, the spectral value will partially fall at the high frequency position. As shown in the waveform below the fourth picture, it can be seen that part of the spectrum value falls above the preset value ft, and part of the spectrum value falls. Below the preset value ft. The fluctuation of the blood pulse signal Vpul actually causes a change in the adjustment parameter Vpar, that is to say, when the fluctuation of the blood pulse signal Vpul is fast, the change of the adjustment parameter Vpar will be fast, that is, the spectrum obtained by the analysis unit 320. The value can also be regarded as a change in the adjustment parameter Vpar.

In order to avoid rapid adjustment of the heart beat frequency in the human body In the section, when the spectral value of the blood pulse signal Vpul in the spectrum is greater than a predetermined value ft, the control unit 330 will decrease the rhythm change of the heart rate control signal Vcon. For example, when the spectral value of the blood pulse signal Vpul in the spectrum is greater than a preset value ft (for example, 0.3 Hz), the control unit 330 determines that the original connection is The received adjustment parameter Vpar (for example, 20 times per second) changes too fast, that is, it may be reduced by 20 times per second from the previous moment to 20 times per second, so the control unit 330 will lower the heart rate control signal. Vcon's rhythm change, such as limiting the rhythm change to 50%, the control unit 330 will limit the previously received adjustment parameter Vpar (20 times per second) to 50% (plus 10 times per second), so the original heart rate control The first fixed rhythm of the signal Vcon (80 times per second) is increased to a second fixed rhythm (90 times per second).

It must be added that when the blood pulse signal Vpul is in the spectrum When the spectral values are less than the preset value ft (for example, 0.3 Hz), the control unit 330 restores the rhythm change of the heart rate control signal Vcon, that is, does not limit the rhythm change of the heart rate control signal Vcon.

Next, please refer to FIG. 5, which illustrates an implementation according to one embodiment of the present disclosure. A schematic diagram of a heart rhythm adjustment method 500 in an example. The heart rhythm adjustment method 500 in this embodiment can be used in the previous embodiment of the heart rhythm adjustment device 300, but not limited thereto, and can also be used on other electronic devices having the same.

As shown in FIG. 5, the heart rate adjustment method 500 in this embodiment First, step S510 is executed to output a heartbeat control signal corresponding to the beat frequency of the heart.

Then, step S520 is performed to extract the blood pulse signal.

Next, step S530 is performed to analyze the amplitude of the blood pulse wave signal and the rebound wave time time of the blood pulse wave signal when the heart rate control signal has the first fixed rhythm.

Next, in step S540, the adjustment parameter is output according to the amplitude of the blood pulse signal and the rebound wave time of the blood pulse signal.

Then, step S550 is performed, and the heart is adjusted according to the adjustment parameter. The law control signal is adjusted from the first fixed rhythm to a different second fixed rhythm.

In summary, the present disclosure provides a blood pulse based on blood Signal-regulated heart rhythm adjustment device and its adjustment method. Through the amplitude of the blood pulse signal and the rebound wave time, the ejection volume rate and the autonomic nerve are analyzed non-invasively, so the heart rate control signal can be adjusted according to different physiological conditions.

The present disclosure has been disclosed in the above embodiments, but it is not intended to limit the disclosure, and any person skilled in the art can make various changes and refinements without departing from the spirit and scope of the disclosure. The scope of protection of the disclosure is subject to the definition of the scope of the patent application.

300‧‧‧heart rate adjustment device

310‧‧‧Sensor unit

320‧‧‧Analysis unit

330‧‧‧Control unit

Vpul‧‧‧ blood pulse signal

Vpar‧‧‧ adjustment parameters

Vcon‧‧‧ heart rate control signal

Claims (10)

A heart rate adjusting device comprises: a control unit for outputting a heartbeat control signal corresponding to a beat frequency of a heart; a sensing unit for capturing a blood pulse signal; and an analyzing unit for the heart rate control signal When the first fixed rhythm is present, the analyzing unit analyzes the amplitude of the blood pulse signal and the rebound wave time of the blood pulse signal, and outputs an adjustment parameter, and the control unit is configured to use the heart rate according to the adjustment parameter. The control signal is adjusted by the first fixed rhythm to a different second fixed rhythm. The heart rate adjusting device of claim 1, wherein the analyzing unit further comprises a spectrum analyzing module, wherein the spectrum analyzing module is configured to analyze a spectral value of the blood pulse signal in the spectrum, the control unit And adjusting the heart rhythm control signal to the second fixed rhythm according to the adjustment parameter and the spectral value. The heart rate adjusting device according to claim 1, wherein the analyzing unit increases the adjusting parameter when an amplitude of the blood pulse wave signal or a rebound wave time of the blood pulse wave signal becomes small. The heart rate adjusting device according to claim 1, wherein the analyzing unit decreases the adjusting parameter when an amplitude of the blood pulse wave signal or a rebound wave time of the blood pulse wave signal becomes large. The heart rate adjusting device of claim 2, wherein the control unit reduces a rhythm change of the heart rate control signal when the spectral value is greater than a predetermined value. A heart rate adjustment method includes: outputting, by a control unit, a heart rate control signal corresponding to a beat frequency of a heart; and obtaining, by the control unit, a blood pulse signal; when the heart rate control signal has a first fixed rhythm, The amplitude of the blood pulse wave signal and the rebound wave time of the blood pulse wave signal are analyzed by an analyzing unit; and the analyzing unit outputs an adjustment according to the amplitude of the blood pulse wave signal and the rebound wave time of the blood pulse wave signal. And adjusting, by the control unit, the heart rhythm control signal from the first fixed rhythm to the different second fixed rhythm according to the adjustment parameter. The heart rhythm adjustment method according to claim 6, wherein a spectrum analysis module of the blood pulse signal is analyzed by a spectrum analysis module in the analysis unit, and the heart rate adjustment method further comprises The control unit adjusts the heart rhythm control signal from the first fixed rhythm to the second fixed rhythm according to the adjustment parameter and the spectral value. The method of heart rate adjustment as described in item 6 of the patent application scope is more The adjusting parameter is included by the analyzing unit when the amplitude of the blood pulse signal or the rebound wave time of the blood pulse signal becomes small. The heart rhythm adjustment method according to claim 6 further includes the step of reducing the adjustment parameter by the analyzing unit when the amplitude of the blood pulse signal or the rebound wave time of the blood pulse signal becomes larger. The heart rhythm adjustment method according to claim 7 further includes: when the spectral value is greater than a preset value, the control unit decreases the rhythm change of the heart rhythm control signal.